Digital Sleep Therapy for Older Adults With Cognitive Impairment — ExCEED  

Cognitive Impairment Clinical Trial

Official title: E-buddy Supported Digital Sleep Therapy for Older Adults With Cognitive Impairment

Status Recruiting

Clinical Trial Summary

This study aims to determine the efficacy of digital Behavioural Therapy for Insomnia (dBTi) compared to online sleep health education (control) at reducing insomnia symptom severity (Insomnia Severity Index: ISI) in older adults (50+ years) with subjective cognitive impairment from baseline compared to week 8.

Clinical Trial Description

Insomnia is a highly prevalent sleep disorder affecting up to 10% of the adult population and reports of over 40% in the older population. Current insomnia treatments focus heavily on symptom management with cognitive behavioural therapy for insomnia (CBTi), in both digital and face-to-face form as the recommended first-line treatment. Despite the strong evidence for digital CBTi, there are a lack of data related to older people and whether digital brief behavioural therapy is efficacious in this population. Recent work shows that sleep plays a critical role in optimising brain function and sleep disturbance is highly prevalent in individuals with cognitive impairment.

The investigators will conduct a fully online study comparing 3-weeks of digital brief behavioural therapy for insomnia (dBBTi) (in addtiotion to an extra optional 3 weeks) against online sleep health education. Participants will be recruited, screened and determined eligibility and consent will be conducted online. Participants will be randomly allocated to either dBBTi delivered via a mobile application called SleepFix or wait-listed control. The SleepFix mobile application delivers sleep restriction therapy using a 4 stage approach to improve sleep efficiency. The control will consist of 3 online sleep health education modules provided bi-weekly with information about sleep and sleep hygiene without any specific insomnia therapy. Participants will be recruited using social media and directed to a website to determine eligibility and then provided access to either the dBBTi (SleepFix) or the control with a link to the first online module.

At baseline, all participants will complete self-reported measures of insomnia, cognition ,sleep, fatigue, sleepiness , anxiety, depression, quality of life and digital health literacy. These will be repeated at follow-up at weeks 8, 16. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Insomnia Type; Sleep Disorder
• Sleep Wake Disorders

• NCT number: NCT05173844
• Study type: Interventional
• Source: Woolcock Institute of Medical Research
• Contact: Christopher Gordon
• Phone: +61 2 9351 0586
• Email: C.Gordon@mq.edu.au
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Completion date: December 31, 2024